1. ‘Safer use of intravenous gentamicin for neonates’ how-to guide

2. Why do we need an alert? Used in 89 per cent of neonatal units Over 500 patient safety incidents reported to NPSA in 2008/2009 Side effects include vestibular and auditory damage, and nephrotoxicity Narrow therapeutic range necessitates regular monitoring of blood serum concentrations

3. Gentamicin pharmokinetic information Gentamicin is a broad spectrum aminoglycoside antibiotic which is widely used in the treatment of neonatal infection. It is not absorbed intestinally and therefore is given by injection. It is associated with a risk of kidney damage and hearing impairment. Adverse effects are particularly associated with patients with poor renal function and where higher gentamicin blood levels and longer duration of therapy have been used.

4. Background to alert development C OLLABORATION E VIDENCE NPSA’s RLS RCA of incidents National survey Literature review Expert working group P ILOT 5 units nationally piloting 6 additional units as controls 8 weeks of data PSA Neonatal Nurses Association

5. What does the alert say? A local gentamicin protocol must be available Local protocol Use the four elements of the care bundle Use care bundle Use small cycles of change with a sample of patients PDSA cycle Measure care bundle compliance daily Measurement All relevant staff should be provided with applicable training Training

6. Local protocol Use care bundle PDSA cycleMeasurementTraining Develop a local gentamicin protocol A local protocol is available that clarifies: The initial dose and frequency of administration Blood level monitoring requirements Arrangements for subsequent dosing adjustments based on blood levels taken

7. Ensure local policies include bundle Local protocol Use care bundle PDSA cycle Measurement Training 24-hour clock format should be used when prescribing Unused time slots in prescription administration record should be blocked out at time of dosing to prevent wrong time dosing Interruptions during the preparation and administration of gentamicin should be minimised by the wearing of a disposable coloured apron by staff to indicate that they should not be disturbed The prescribed dose of gentamicin should be given within one hour of the prescribed time A double- checking prompt should be used during the preparation and administration of gentamicin 24-hour clock Coloured apron Double- checking Dose within one hour

8. Double checking prompt Local protocol Use care bundle PDSA cycle Measurement Training

9. PDSA cycle applied to gentamicin Local protocol Use care bundle PDSA cycleMeasurementTraining Ensure compliance charts, audit charts and double- checking prompts are all available Collect data Analyse the data at monthly data review meetings What elements of the care bundle need addressing? Do we understand the measures we are using? Who will analyse the data? How often will data be analysed? Share your results with your staff and senior leaders Implement identified actions arising from your data analysis ActPlan DoStudy

10. Add more patients after each cycle Local protocol Use care bundle PDSA cycleMeasurementTraining Start the actions in the alert for one patient and move through the PDSA cycle When your run chart shows at least 80 per cent compliance add more patients and start the cycle again This process should be repeated from one patient, to three, to five, etc. (this is the 1:3:5 approach)

11. Local protocol Use care bundle PDSA cycleMeasurementTraining Three steps to measurement Fill out compliance chart (appendix A) after each administration of gentamicin Use above compliance charts to populate audit charts (appendix B) Use above weekly audit charts to populate extranet on a monthly basis

12. Local protocol Use care bundle PDSA cycleMeasurementTraining Complete the compliance chart Care bundle compliance chart Care bundle daily audit chart Extranet / run chart 243 128 4627 01/01/201016.07

13. Local protocol Use care bundle PDSA cycleMeasurementTraining Complete the compliance chart Care bundle compliance chart Care bundle daily audit chart Extranet / run chart

14. Local protocol Use care bundle PDSA cycleMeasurementTraining Fill out the audit chart and totals Care bundle compliance chart Care bundle daily audit chart Extranet / run chart

15. Upload audit totals on the extranet Local protocol Use care bundle PDSA cycleMeasurementTraining Care bundle compliance chart Care bundle daily audit chart Extranet / run chart From the daily audit chart

16. Upload audit totals on the extranet Local protocol Use care bundle PDSA cycleMeasurementTraining Care bundle compliance chart Care bundle daily audit chart Extranet / run chart

17. Helpful resources Local protocol Use care bundle PDSA cycleMeasurementTraining In addition to these slides you can also expect the following resources to aid in your implementation: Instructional Webinar presentations FAQs published on the website Resources on PDSA cycles and measurement from the Patient Safety First and 1000 Lives campaign websitesPatient Safety First1000 Lives campaign

18. Therapeutic drug monitoring: why do it? Prevent drug toxicity Ensure drug efficacy

19. Principles of therapeutic drug monitoring Understand what you are measuring pre-dose trough concentration post-dose peak concentration checking efficacy and/or clearance Check when you should be taking levels Interpret the results leave the dose as is adjust the dose and/or the dosing interval question if you need to resample and, if so, when Communicate and document your actions and escalate any concerns if necessary Be sure to follow your local gentamicin policy when progressing through the above principles

20. Support with the measurement extranet Patient Safety First Office: 020 79279569 or www.patientsafetyfirst.nhs.uk www.patientsafetyfirst.nhs.uk 1000 Lives Office (Wales): 029 20827651 or www.1000livescampaign.wales.nhs.uk or the 1000 Lives Campaign contact for the Health Board www.1000livescampaign.wales.nhs.uk

21. Queries about the alert Please email gentamicin@npsa.nhs.uk or call 020 79279514gentamicin@npsa.nhs.uk